• Part I Summary of the dossier

   • Part II Chemical/pharmaceutical/biological documentation

   • Part III Safety and residues documentation

   • Part IV Preclinical and clinical documentation

   • Part V General Conclusions

 

  Part I is an overall summary of the application dossier:

 

   • Section A contains administrative information such as the name of the active ingredient(s) and formulated product(s), the strength and route of administration and description of the pack, names and addresses of the applicant, manufacturers and importers, etc.

   • Section B gives a Summary of the Product Characteristics (SPC), the proposed label and package insert and details, if relevant, of SPC's previously approved.

   • Section C are the "Expert Reports" covering chemical and analytical details, safety and residue details (not usual for pet products), and clinical details (biological efficacy).

 

It is possible to use the so called "Drug Master File" (DMF) procedure and this is especially useful where one company manufactures an active ingredient which it may license to a third party for use as a veterinary medicine but may not be willing to pass over detailed manufacturing or other information.

 

Here, the submission can be in two parts. One is the "Applicants Part" and will typically be information generated by the veterinary medicines company on the end-use product. The other in the "Restricted Part" and is likely to be the manufacturing details and exact composition of the active ingredient. This is supplied directly to the regulatory authorities by the manufacturer.

 

Part II of the MAA is very important as it covers all aspects relating to the quality of the product. Veterinary (and human) medicines in the EU must be manufactured according to the principals of "Good Manufacturing Practice" (GMP). In this part of the application details have to be given for the manufacturing procedures of actives and products (also containers as appropriate). Quality control testing details and storage stability information are especially important. An environmental risk assessment is also a section in this part.

 

Part III of the application covers all the studies required to demonstrate the safety of the product. This will be physico/chemical studies, mammalian and, where necessary, ecotoxicity testing, and residue documentation. Toxicological testing is mainly required for use on food producing animals, not so much for companion animals. Some testing of the end use product will be necessary but these are typically simple short-term acute studies. Similarly, residue data is only relevant for a veterinary product that will be used on animals which are human food items and so testing will not be required for a cat/dog product. However, where residue studies are required, they contribute significantly to the development cost.

 

Part IV covers the efficacy of the product and will always be required. This is in two parts and follows the classical "pre-clinical" and "clinical" requirements common to human and veterinary medicines. In the pre-clinical part it is necessary to show acceptability to the target species and susceptibility of the parasite, usually in separate studies. The issue of resistance must be addressed here as well. In the clinical documentation there must be results of studies that were conducted using the product according to the proposed label recommendations.

 

Part V is only required for immunologicals and consists of a discussion of the results from product specific studies. The nature of the information can vary widely depending on the indication or the properties of the immunological.